It’s time for the UK to bring drug approval into the 21st century

Settling Brexit has been a byzantine process, but it’s got nothing on the UK’s opaque and outright baffling system of pharmaceutical drug availability and research.

Every year the Medicines and Healthcare Products Regulatory Agency (MHRA), the UK’s national drug regulator, approves dozens of new medicines, including both the newest patented medicines and lower-cost generic drugs.

After Brexit the MHRA will have a much bigger role as the European Medicines Agency (EMA) will likely no longer be responsible for the approval of innovative drugs in the UK. But the UK has an outdated and murky approach to patenting and regulatory approval that leaves patients in the dark.

Bracing for Brexit means also that we need to bring our drug approval system to the 21st century and include openness and transparency.

Instead of regularly notifying which drugs are approved and their patent status, the UK hides much of this information. This makes it harder for patients and healthcare professionals to know which drugs are currently available and will soon be at the pharmacy. This stands in stark contrast to the international trend of promoting more transparency in pharmaceutical markets.

And while the EMA has such a notification mechanism set up for certain innovative and orphan medicines, the UK does not. An open and transparent government should provide patients, doctors and pharmacists with the information on which drugs manufacturers are currently filing for market authorisation.

At the moment, you can find six pages in MHRA’s annual report on its energy use, but precious little on the current approval and application pipeline. Shouldn’t patients have access to this information?

We should follow international best practices and publicly release more information about drugs being considered for approval. This should include information about the patent status of these drugs and the timeline for approval.

Canada provides a good example of how to go about this. Its Patented Medicines Regulations allow the timely release of this information and keep patients better informed about their health care options. It also helps to hold the government accountable, leading to a more transparent and functional drug approval process.

Other advanced countries, including Singapore, have open systems in which governments transparently and efficiently review the patent status of new medicines prior to marketing approval. This transparency makes markets work better and brings down costs and prices.

The UK is not alone in needing more patient-friendly transparency and open government: France and Italy both lack having an easy-to-access database that lists all approved drugs and drugs in review.

Increased transparency of patent information and regulatory approval helps patients in a number of ways. It can help bolster intellectual property protections essential to getting the newest, most effective medicines to market. It can also help speed up the process of approving lower-cost generic medicines that could immediately save lives.

Patients should demand the implementation of an online database that not only lists currently approved patent-protected drugs and generics but also shows in real-time which marketing authorisations are being sought by patented and off-patent drugs. Ideally, drug manufacturers would apply for marketing authorisation in the UK through that open platform as well. This would allow a one-stop-shop for patients, health care professionals, and the pharmaceutical industry.

In the age of Amazon, TripAdvisor, and Ocado, it’s about time that our public administration helps bring more transparency and live data to patients and doctors. Any delay means keeping patients in the dark – and we all deserve better.

Originally published here.


The Consumer Choice Center is the consumer advocacy group supporting lifestyle freedom, innovation, privacy, science, and consumer choice. The main policy areas we focus on are digital, mobility, lifestyle & consumer goods, and health & science.

The CCC represents consumers in over 100 countries across the globe. We closely monitor regulatory trends in Ottawa, Washington, Brussels, Geneva and other hotspots of regulation and inform and activate consumers to fight for #ConsumerChoice. Learn more at 
consumerchoicecenter.org

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